check_circleStudy Completed

Hemophilia A

Bayer Identifier:

13401

ClinicalTrials.gov Identifier:

NCT01184820

EudraCT Number:

Not Available

EU CT Number:

Not Available
Trial to evaluate the pharmacokinetics and safety profile of BAY94-9027 following single and multiple dose administration

Trial purpose

The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test drug). Pharmacokinetics means that we will measure how well the study drug corrects the factor VIII levels in your blood and how long it takes for the levels to fall back to your baseline level. The study is also designed to determine if the pharmacokinetics of BAY94-9027 change following repeat dosing over 8 weeks, determine if BAY94-9027 is safe, tolerable, and effective for the treatment of severe hemophilia A and define the appropriate dose of BAY94-9027. Two doses of BAY94-9027 will be studied.
The first 8 subjects enrolled in the study (cohort 1) will receive a low dose (25 IU/kg) and will be treated 2 days a week for 8 weeks (total of 16 doses). The second 8 subjects (cohort 2) will receive a higher dose and will be treated 1 day a week for 8 weeks (total 8 doses). All subjects will receive a single dose of rFVIII (Bayer Kogenate FS) to determine the PK by measuring blood levels for 2 days before they start the study drug BAY94-9027. Factor VIII blood levels for BAY94-9027 will be measured for 7 days after the first and last dose to see describe the PK. Safety & tolerability assessment include vital signs, coagulation and hematological parameter, clinical chemistry, measurement of FVIII inhibitor and polyethylene glycol (PEG) antibodies will be done during the course of the study.

Key Participants Requirements

Sex

Male

Age

18 - 65 Years
  • - Male subjects with severe hemophilia A (documented plasma baseline Factor VIII level <1 %)
    - >/= 18 but - Previously treated with Factor VIII concentrate(s) for a minimum of 150 exposure days (as supported by the subject's medical history)
    - Immunocompetent with a CD4+ lymphocyte count > 400/mm³
    - Signed informed consent from subject
  • - Documented history of inhibitor to Factor VIII with a titer >/= 0.6 BU (Biological Unit), by the Nijmegen modified assay. However, subjects with a maximum historical titer of - Unable to stop Factor VIII treatment to complete a minimum 72 hour washout
    - Current evidence of inhibitor to Factor VIII with a titer >/= 0.6 BU, measured at the time of screening
    - Abnormal renal function (serum creatinine > 1.5 times the upper limit of the normal range)
    - Total bilirubin > 1.5 times the upper limit of the normal range
    - Active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels > 2 times the upper limit of the normal range)
    - Any concomitant coagulation disorder other than hemophilia A (including lupus anticoagulant)
    - Platelet count < 100,000/mm³
    - Within the last 3 months prior to study entry or during the study will be treated with an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a interferon, steroids, rituximab, etc)
    - Any subject who requires major surgery during study period. Minor procedures may be approved if discussed in advance with the medical expert.

Trial summary

Enrollment Goal
14
Trial Dates
October 2010 - October 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Boston, 02115-6195, United States
Completed
Syracuse, 13210, United States
Completed
Davis, 95616, United States
Withdrawn
New Brunswick, 08901, United States
Completed
Minneapolis, 55455, United States
Withdrawn
New Orleans, 70112-2699, United States

Primary Outcome

  • Safety as assessed by measuring immunogenicity
    Antibodies to FVIII, polyethylene glycol (PEG) and BAY94-9027
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Adverse events collection
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Area under the plasma concentration vs time curve from time 0 to the last data point (AUC0-tlast)
    date_rangeTime Frame:
    Up to 8 weeks
  • Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC0-inf)
    date_rangeTime Frame:
    Up to 8 weeks
  • Maximum drug concentration in plasma (Cmax)
    date_rangeTime Frame:
    Up to 8 weeks
  • Half-life associated with the terminal slope (t1/2)
    date_rangeTime Frame:
    Up to 8 weeks
  • Time to reach maximum drug concentration in plasma after single (first) dose (Tmax)
    date_rangeTime Frame:
    Up to 8 weeks
  • Mean residence time (MRT)
    date_rangeTime Frame:
    Up to 8 weeks
  • Total body clearance (CL)
    Total body clearance of drug from plasma (volume/time) or (volume/time/body weight) or ((volume/time)*(1.73/body surface area)) calculated after intravenous administration
    date_rangeTime Frame:
    Up to 8 weeks
  • Apparent volume of distribution at steady state (Vss)
    Based on the chromogenic, one-stage and PEG capture assays
    date_rangeTime Frame:
    Up to 8 weeks
  • Incremental recovery of FVIII
    Recovery was assessed using two different assays (chromogenic and one-stage assay)
    date_rangeTime Frame:
    Up to 8 weeks

Trial design

An open-label Phase 1 trial to evaluate the pharmacokinetics and safety profile of BAY94-9027 following single and multiple dose administration in two cohorts of previously treated male subjects with severe hemophilia A
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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